Organ TransplantationPhase 1NCT00987103
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
A Phase 1 study testing Tacrolimus in people with Organ Transplantation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Organ Transplantation
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included.
- Age: 18 - 65 years
- Patient's informed consent
Who cannot join
- Patients that use drugs that interact with tacrolimus
- Patients that participate in other studies
- Patients that are treated with tacrolimus
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Hospital
Maastricht, 6229 HX
Afke van de Plas, Hospital Pharmacist, +31433874733, a.vande.plas@mumc.nl
Johannes van Hooff, Professor
About this study
The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.
- Conditions
- Organ Transplantation
- Being tested
- Tacrolimus
- Keywords
- renal transplantation, tacrolimus, pharmacokinetics, rectal, sublingual, rectal administration, sublingual administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograft
Oral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Sublingual - Rectal - Oral | Experimental | Administration order of rank: Sublingual - Rectal - Oral Receives: Drug: Tacrolimus |
| Sublingual - Oral - Rectal | Experimental | Administration order of rank: Sublingual - Oral - Rectal Receives: Drug: Tacrolimus |
| Oral - Sublingual - Rectal | Experimental | Administration order of rank: Oral - Sublingual - Rectal Receives: Drug: Tacrolimus |
| Oral - Rectal - Sublingual | Experimental | Administration order of rank: Oral - Rectal - Sublingual Receives: Drug: Tacrolimus |
| Rectal - Sublingual - Oral | Experimental | Administration order of rank: Rectal - Sublingual - Oral Receives: Drug: Tacrolimus |
| Rectal - Oral - Sublingual | Experimental | Administration order of rank: Rectal - Oral - Sublingual Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve, bioavailability, time of maximal concentration, elimination constant
Measured: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Johannes van Hooff, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987103
- Sponsor's protocol ID
- 09-2-016
- Status last verified
- Oct 2010
- First submitted
- 29 Sep 2009
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT00987103
- Acronym / sponsor ID
- 09-2-016
- Conditions
- Organ Transplantation
- Keywords
- renal transplantation, tacrolimus, pharmacokinetics, rectal, sublingual, rectal administration, sublingual administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sublingual - Rectal - Oral | Experimental | Drug: TacrolimusAdministration order of rank: Sublingual - Rectal - Oral |
| Sublingual - Oral - Rectal | Experimental | Drug: TacrolimusAdministration order of rank: Sublingual - Oral - Rectal |
| Oral - Sublingual - Rectal | Experimental | Drug: TacrolimusAdministration order of rank: Oral - Sublingual - Rectal |
| Oral - Rectal - Sublingual | Experimental | Drug: TacrolimusAdministration order of rank: Oral - Rectal - Sublingual |
| Rectal - Sublingual - Oral | Experimental | Drug: TacrolimusAdministration order of rank: Rectal - Sublingual - Oral |
| Rectal - Oral - Sublingual | Experimental | Drug: TacrolimusAdministration order of rank: Rectal - Oral - Sublingual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included.
- Age: 18 - 65 years
- Patient's informed consent
Key exclusion criteria (3 listed)
- Patients that use drugs that interact with tacrolimus
- Patients that participate in other studies
- Patients that are treated with tacrolimus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: PrograftOral: 0,1 mg/kg Rectal: 15 mg Sublingual: 0,04 mg/kg | Drug | Oral - Rectal - Sublingual, Oral - Sublingual - Rectal, Rectal - Oral - Sublingual, Rectal - Sublingual - Oral, Sublingual - Oral - Rectal, Sublingual - Rectal - Oral |
Primary outcome
Area under the curve, bioavailability, time of maximal concentration, elimination constant
Time frame: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes van Hooff, Professor principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tacrolimus in people with Organ Transplantation, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afke van de Plas, Hospital Pharmacist (+31433874733, a.vande.plas@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve, bioavailability, time of maximal concentration, elimination constant (time frame: t = 0, ½, 1, 2, 4, 8, 12, 24, 36 and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2010.